Probiotic Yogurt in Patients With Chronic Cholecystitis (GR5-CC)
Efficacy and Safety of Pediococcus Acidilactici GR-5 in Patients With Chronic Cholecystitis: A Randomized Double-Blind Placebo-Controlled Trial
Background and Purpose: Chronic cholecystitis is a common disease causing gallbladder inflammation, which is closely related to imbalances in gut bacteria and bile acids. This study aims to investigate whether consuming a special functional yogurt containing the probiotic Pediococcus acidilactici GR-5 can help alleviate the symptoms of chronic cholecystitis.
Study Procedures: Researchers will recruit 50 patients with chronic cholecystitis and randomly divide them into two groups. For 30 days, one group will consume the functional GR-5 probiotic yogurt, while the other group will consume regular commercial yogurt (placebo). During the study period, researchers will use abdominal imaging to check the gallbladder, evaluate clinical symptoms, and collect blood and stool samples at baseline and after the 30-day intervention. The goal is to see if this probiotic yogurt can improve gallbladder health by regulating gut bacteria and bile acid metabolism, potentially providing a new dietary and nutritional option for patients with cholecystitis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Scientific Background: The pathogenesis of chronic cholecystitis is closely associated with the accumulation of conjugated bile acids and the dysbiosis of gut microbiota. Previous studies indicate that Pediococcus acidilactici GR-5, a probiotic isolated from traditional fermented foods, possesses high bile salt hydrolase (BSH) activity. It can efficiently deconjugate bile acids, thereby potentially reducing cytotoxicity and inflammatory stimulation in the gallbladder mucosa. This study aims to evaluate the clinical efficacy and underlying mechanisms of GR-5 functional yogurt in managing chronic cholecystitis via the "gut-biliary axis."
Study Design and Intervention: This is a prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible patients diagnosed with chronic cholecystitis will be randomly assigned in a 1:1 ratio to receive either the functional GR-5 probiotic yogurt (intervention group) or an ordinary yogurt without GR-5 (control group) for 30 days. To ensure strict double-blinding, an independent third party will handle the generation of the random sequence and the de-identified packaging. Both yogurt products will be completely identical in appearance, color, smell, and taste.
Data Collection and Multi-omics Analysis: The observation period spans 30 days. At baseline (Day 0) and at the end of the intervention (Day 30), researchers will conduct clinical evaluations, morphological imaging of the biliary tract, and collect fasting peripheral blood and fecal samples. To explore the deep mechanisms, multi-omics technologies, including 16S rRNA high-throughput sequencing and targeted/untargeted metabolomics of bile acids, will be utilized. By dynamically monitoring the changes in the gut microbiome and bile acid metabolic profiles before and after the intervention, this study expects to provide scientific evidence for using targeted functional microecological therapies to reshape intestinal homeostasis and alleviate biliary inflammation.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: wei xiang, phD
- Número de teléfono: +86 13811760257
- Correo electrónico: xiangw2023@lzu.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: wei xiang
- Número de teléfono: 13811760257
- Correo electrónico: xiangw2023@lzu.edu.cn
Ubicaciones de estudio
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Gansu
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Lanzhou, Gansu, Porcelana, 730000
- School of Life Sciences, Lanzhou University
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Contacto:
- wei xiang, phD
- Número de teléfono: +86 13811760257
- Correo electrónico: xiangw2023@lzu.edu.cn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male or female, aged 18 to 70 years.
- Definitive diagnosis of chronic cholecystitis (with or without gallstones), referencing the Chinese Medical Association guidelines or relevant clinical diagnostic criteria.
- Presence of clinical symptoms including recurrent right upper quadrant discomfort or dull pain, or accompanying dyspeptic symptoms (such as abdominal bloating, belching, or nausea), with symptoms persisting or recurring for more than 3 months prior to enrollment.
- Imaging support: Abdominal ultrasound within 3 months prior to enrollment indicating gallbladder wall thickening (typically > 3 mm) or wall roughness.
- Voluntary participation and signed written informed consent form.
Exclusion Criteria:
- Acute exacerbation of cholecystitis, purulent or gangrenous cholecystitis, or accompanying biliary obstruction or severe cholangitis requiring emergency surgical intervention.
- History of cholecystectomy or other major gastrointestinal surgeries (e.g., gastric bypass, bowel resection).
- Comorbidities of other severe primary diseases or malignancies, including: severe cardiovascular, renal, or neurological diseases; severe liver diseases (e.g., cirrhosis, severe viral hepatitis); and malignancies (e.g., gallbladder cancer, gastrointestinal tumors).
- Pregnant or lactating women, or those planning to conceive during the study period.
- Use of the following medications or preparations within 4 weeks prior to enrollment: continuous use of antibiotics, other probiotic or prebiotic preparations; currently taking choleretic or litholytic drugs that may significantly affect bile acid metabolism (e.g., ursodeoxycholic acid).
- Known allergy to dairy products, yogurt, or any intervention ingredients, or having severe lactose intolerance.
- Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this clinical study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental Group: GR-5 Yogurt
Participants assigned to this group will receive the functional yogurt containing Pediococcus acidilactici GR-5 (zero sucrose) daily for 30 days.
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A functional yogurt product provided by Jiangruikang Company, containing the probiotic strain Pediococcus acidilactici GR-5, with zero sucrose.
Participants will consume it daily for 30 days.
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Comparador de placebos: Placebo Comparator Group
Participants assigned to this group will receive regular commercial yogurt (zero sucrose, without GR-5 probiotic) daily for 30 days.
It is identical in appearance, color, smell, and taste to the functional yogurt.
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An ordinary commercial yogurt product provided by Jiangruikang Company, with zero sucrose but without the GR-5 probiotic.
It is identical in appearance, color, smell, and taste to the functional yogurt.
Participants will consume it daily for 30 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Gallbladder Wall Thickness and Smoothness
Periodo de tiempo: Baseline and Day 30
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Assessed via abdominal ultrasound.
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Baseline and Day 30
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in Gut Microbiota Diversity and Abundance
Periodo de tiempo: Baseline and Day 30
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Analyzed using 16S rRNA gene sequencing of fecal samples.
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Baseline and Day 30
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Change from Baseline in Serum Metabolite Levels
Periodo de tiempo: Baseline and Day 30
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Measured using metabolomics analysis of blood samples.
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Baseline and Day 30
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Change from Baseline in Fecal Metabolite Levels
Periodo de tiempo: Baseline and Day 30
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Measured using metabolomics analysis of stool samples.
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Baseline and Day 30
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Change from Baseline in Liver Function Indicators
Periodo de tiempo: Baseline and Day 30
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Measured via standard serum biochemical analysis (including ALT, AST, ALP, and Bilirubin)
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Baseline and Day 30
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Change from Baseline in Complete Blood Count (CBC)
Periodo de tiempo: Baseline and Day 30
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Measured via standard hematology analysis.
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Baseline and Day 30
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Incidence of Treatment-Emergent Adverse Events
Periodo de tiempo: Up to Day 30
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Assessed through patient reporting, clinical observation, and physical examination.
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Up to Day 30
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: xiangkai Li, phD, School of Life Sciences, Lanzhou University
- Investigador principal: wei xiang, School of Life Sciences, Lanzhou University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- LZU-CC-GR5-2026
- 32370110 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
- 24ZDWA005 (Otro número de subvención/financiamiento: Gansu Province Science and Technology Major Project)
- 2026004 (Otro identificador: Pingliang Hospital of Integrated Traditional Chinese and Western Medicine)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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